Director Real World Evidence Scientist (Oncology)

EMD Serono Research & Development Institute•Billerica, MA

43d

About The Position

An exciting opportunity awaits you within the Patient Focused Real World Evidence (PRWE) Team. As passionate leaders of patient focused real world data, evidence generation, and epidemiology, we are uniquely placed to enable fit-for-purpose visionary solutions with real world and patient focused data from early development and throughout the drug life span. Our team operates with a proactive and agile approach, as a trusted partner in qualitative and quantitative sciences, all while striving towards the common goal to deliver more medicines to more patients faster. As a key member of our team, you will drive the Real-World Evidence and Data (RWE/D) strategy and studies across the lifecycle of drugs, with a particular focus on drug development and excellence in integrated evidence planning. You will provide scientific leadership and expertise to ensure that fit-for-purpose RWD are integrated in evidence generation plans and available in a timely manner to support regulatory submissions and program´s decision-marking. You will lead the quantitative strategy of RWE/D for your therapeutic area and to provide evidence for Integrated Evidence Plans You will lead the design, implementation and oversight of disease or drug-specific Non-Interventional (NIS) / RWE studies, encompassing safety related studies, external control arm studies, and regulatory grade studies. Your work will involve inspiring cross-functional collaboration, in a unique partnership with other quantitative scientists while maintaining and expanding our external collaborations.

Requirements

Doctoral and/or master’s degree (e.g., PhD, MSc) in Epidemiology, Public Health or related field
Strong experience in RWE/D within the pharmaceutical industry, particularly in the application of RWE in drug development for rare indications

Nice To Haves

Preferably a background in health and life sciences (MD, pharmacist epidemiology, public health), or quantitative data sciences, biostatistics
Demonstrable experience in leading RWE generation plans and studies end-to end, including application of innovative designs and methods
Excellent oral and written communication skills and demonstrated ability to engage and communicate scientific evidence to peers and at scientific meetings
Collaborative, proactive working style, with ability to work independently.

Responsibilities

Drive the Real-World Evidence and Data (RWE/D) strategy and studies across the lifecycle of drugs, with a particular focus on drug development and excellence in integrated evidence planning.
Provide scientific leadership and expertise to ensure that fit-for-purpose RWD are integrated in evidence generation plans and available in a timely manner to support regulatory submissions and program´s decision-marking.
Lead the quantitative strategy of RWE/D for your therapeutic area and to provide evidence for Integrated Evidence Plans
Lead the design, implementation and oversight of disease or drug-specific Non-Interventional (NIS) / RWE studies, encompassing safety related studies, external control arm studies, and regulatory grade studies.
Inspire cross-functional collaboration, in a unique partnership with other quantitative scientists while maintaining and expanding our external collaborations.